Clonazepam Tablets, USP, CIV, Rx only

/Clonazepam Tablets, USP, CIV, Rx only
Clonazepam Tablets, USP, CIV, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

Clonazepam Tablets, USP, CIV, Rx only

ID:

4dcb6785-e16b-4692-89b3-f905979ca5ae

Code:

34391-3

DESCRIPTION


id: c4b965a8-22ba-49e3-b61c-edbd89d079f2
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Clonazepam, a benzodiazepine, is available as scored tablets debossed with “1” and “2” containing 0.5 mg of clonazepam and unscored tablets debossed with “C 1” on 1 mg tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of clonazepam. Each tablet contains anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:

CONTRAINDICATIONS


id: f65bc920-2fd8-48fd-b23e-c7d52e27bfd9
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Clonazepam should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

ADVERSE REACTIONS


id: 5b15f3d8-0f02-4aeb-8ed4-55efa97cbc99
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.

DOSAGE AND ADMINISTRATION


id: f07f66c5-9364-41db-8b86-7f5a79396759
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.

HOW SUPPLIED


id: 360b2217-a47d-45b5-a6f6-988a97f83dc7
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows: Bottles of 30       NDC 63187-603-30 Bottles of 60       NDC 63187-603-60 Bottles of 90       NDC 63187-603-90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Manufactured For:

Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA. Manufactured By:

Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
India. Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 10 7744 1 626035 Issued October, 2010.

PRINCIPAL DISPLAY PANEL – 0.5 mg


id: cb08e8f9-aca6-4eda-bfe9-428b0c2a4b44
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 63187-603-60 CLONAZEPAM CIV

TABLETS, USP

0.5 mg Rx Only Pharmacist: Must be dispensed with Medication Guide. 60 TABLETS accord